NCT02264418已完成1 期
Safety and Tolerability of Single and Repeated Doses of ODM-203: An Open-label, Non-randomised, Uncontrolled, Dose Escalation, Multicentre, First-in-Human Study in Subjects With Advanced Solid Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 8
- 主要终点
- Number of adverse events
研究概览
简要总结
The purpose of this first-in-human study is to evaluate the safety and tolerability of escalating doses of ODM-203 in subjects with advanced solid tumours and to determine the maximum tolerated dose and dose limiting toxicities.
详细描述
The safety profile of ODM-203 will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with ODM-203 to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of ODM 203 will be evaluated after single and multiple dose administrations at different dose levels
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Male and female subjects over 18 years of age
- •Subjects with histologically or cytologically confirmed locally advanced or metastatic tumours. Subjects in Part 2 to have a tumour/genetic aberration.
- •Availability of tumour sample for genetic analysis
- •Adequate haemopoietic, hepatic and renal function
- •Eastern Cooperative Oncology Group performance status of 0 to 1
- •Serum mineral levels phosphate: 2.5 mg/dl; calcium: 8.8 mg/dl; magnesium: 1.2 mg/dl; potassium: 11.7 mg/dl; sodium: 299mg/dl.
- •Recovery from reversible adverse events of previous systemic anti-cancer therapies to baseline or grade 1 with the exception of alopecia;stable neuropathy of grade 2 induced by previous cancer treatment
- •Life expectancy of 12 weeks or more
排除标准
- •Any prior anti VEGFR/FGFR treatment related AE that in the judgement of the investigator is considered severe/life threatening
- •Subjects receiving warfarin
- •Active central nervous system metastases not controlled by prior surgery/radiotherapy and/or low dose steroids for 4 weeks or more
- •Subjects with current evidence of endocrine alteration of calcium-phosphate homeostasis
- •Concomitant therapies known to increase serum phosphorus and/or calcium levels that cannot be discontinued or switched to a different therapy are not permitted within 14 days before the first dose of ODM-
- •Significant cardiovascular conditions/circumstances as follows:
- •a active or unstable cardio/cerebro-vascular disease
- •b Uncontrolled hypertension (systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 90mg Hg with optimised antihypertensive therapy.
- •c history of severe arrhythmia, familial arrhythmia, conduction abnormality or congenital long QT syndrome
- •dConcomitant therapies known to prolong the QT interval and associated with a risk of Torsades de Pointes are not permitted within 7 days before the first dose of ODM 203
- •e Repeatable prolongation of QTcF interval ≥ 450 msec or any clinically significant abnormality in the ECG at screening in 2 out of 3 recordings
- •f Left ventricular ejection fraction <50% at screening
- •Subjects who received systemic anticancer treatment prior to the first dose of ODM-203 within the following timeframes: less than 28 days since the last dose of antineoplastic therapy and/or 28 days of wide field radiotherapy or 14 days of limited field radiation for palliation
- •Major surgery or serious infection within 21 days of the first dose of ODM-203
- •Known gastrointestinal disease or a procedure that may affect absorption of ODM 203
- •Serious concurrent medical condition or psychiatric illness
- •History and/or current evidence of ectopic mineralisation/calcification
- •Known active or past history of other primary malignancy
- •Female of child bearing potential
- •Female of child bearing potential or male subject with a female partner of child bearing potential who does not agree to use effective contraception during the study and for 3 months after the last dose of ODM 203
- •Known hypersensitivity to the study treatment excipients
- •Any condition which in the opinion of the investigator would impair the subject's ability to comply with the study procedures
- •Participation in another interventional clinical trial/ concurrent treatment with any investigational drug within 4 weeks prior to the start of treatment with ODM 203
研究组 & 干预措施
ODM 203
Experimental
Oral capsules given once daily dosage 50-800mg
干预措施: ODM 203 (Drug)
ODM-203
Experimental
Oral tablets given once daily 200-1600mg
干预措施: ODM 203 (Drug)
结局指标
主要结局
Number of adverse events
时间窗: From the date of informed consent to the date of the end of study visit estimated to be 6 months
Number of adverse event counts
次要结局
- Frequency of responders to Response evaluation criteria in solid tumours (RECIST)(Subjects will be followed for the duration of time in the study, expected to be an average of 6 months)
- Peak plasma concentration (Cmax)(After first dose administration to 24 hours Day 1 and Day 15)
- Area under the plasma concentration curve (AUC)(0 to 24hours post dose Day 1 and Day 15)
- Eastern Cooperative Oncology Group (ECOG) Performance status(Subjects will be followed for the duration of time in the study, expected to be an average of 6 months)
研究者
研究点 (8)
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